# FDA 483 - Dental Technologies, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/dental-technologies-inc/39710eed-a303-47cd-914e-67d601131b64

> FDA 483 for Dental Technologies, Inc. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dental Technologies, Inc.
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Dental Technologies, Inc. in Lincolnwood, IL, a drug manufacturer, was inspected by the FDA from December 2020 to January 2021. The inspection revealed significant deficiencies across its quality control unit, investigations, microbiological testing, water system, cleaning procedures, and documentation. These issues indicate a systemic failure to ensure drug product quality and prevent contamination, particularly with objectionable microorganisms like Burkholderia cepacia and Pseudomonas aeruginosa.

## Related Officers

- [Nibin Varghese](https://www.keypedia.com/people/nibin-varghese/43e17f63-2c1f-4d46-b26f-dc8ac8885438)
- [Brian D. Nicholson](https://www.keypedia.com/people/brian-d-nicholson/83ea13dd-6753-468a-a0ca-19e3ef4158dd)
- [issuing_officer](https://www.keypedia.com/people/vioela-j-caze/919a30c8-26e5-4908-a73c-4e8cba5692cf)
- [Michele L. Glendenning](https://www.keypedia.com/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)

Company: https://www.keypedia.com/companies/dental-technologies-inc/53bf17bc-eb03-49a0-9849-70a276517b02

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669